Key People

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Statistician, *MSc in Statistics or equivalent, biostatistics and SAS programming

Salary :

£45000 - £58000 per annum

Date Posted :

03 Apr, 2018

Company Name :

Key People

Location1 :

Oxfordshire

Job Category :

Biostatistics Jobs

Experience :

Fresher

Job Type:

Permanent

Travel Amount:

100.00%

Description

The scope of responsibilities will include:
*Leading all biostatistics activities related to clinical trials as responsible project statistician
*Communication line for project teams, clients, and vendors on statistical questions
*Development and review of statistical sections of protocols, including sample size calculations
*Development of statistical analysis plans
*Development and documentation of analysis database structures (i.e. SAS analysis data set structures)
*Development of SAS program requirements and specifications
*SAS programming and program validation
*Review and QC of statistical deliverables (tables, listings, figures, etc.)
*Performing statistical analysis and reporting results
*Providing consultation on experimental design, statistical methods, and approaches for the purpose of assessing safety and efficacy of drug products
*Liaison with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
*Participation in bid defense meetings and kick-off meetings
*Preparation and delivery of presentations at investigators' meetings
*Coaching and training of statisticians and SAS programmers
*Preparation for and attendance at internal and third-party study audits pertinent to Statistics
*Preparation of the answers to the internal/external audits findings/recommendations, and follow-up on and resolution of audit findings
*Participation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department
The ideal candidate will have:
*MSc in Statistics or equivalent
*Relevant industry experience in clinical research, including significant experience in biostatistics and SAS programming
*Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
*Very Good knowledge and understanding of the SAS programming language
*Strong ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
*Strong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
*Strong ability to represent Biostatistics in bid defenses
*Strong knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
The ideal candidate's skills include:
*Excellent presentation and communication skills
*Advanced knowledge of SAS software
*Good knowledge of MS office software
*Advanced knowledge of CDISC ADaM IG 1.0 or later, define1-0-0.xml and define2-0-0.xml specifications
*Knowledge of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software is a plus

Company Name:

Key People

Headquarters:

Catherine House,Adelaide Street

Sector:

Staffing Firms

Country:

United Kingdom

Zipcode:

AL3 5BA

Website:

www.keypeople.co.uk

Employees:

less than 100

Industry:

Pharmaceutical

City:

St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.